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New Delhi, Jul 6: The Indian Academy of Sciences, a Bengaluru-based body of scientists, has said the Indian Council for Medical Research's (ICMR) target to launch a coronavirus vaccine by August 15 is "unfeasible" and "unrealistic".

The IASc said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

While administrative approvals can be expedited, the "scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour", the IASc said in a statement.

In its statement, the IASc referred to the ICMR's letter which states that "it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".

The ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing the vaccine against the novel coronavirus -- SARS-CoV-2.

The IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use, the statement said.

"However, as a body of scientists including many who are engaged in vaccine development IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens," it said.

Aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate, COVAXIN.

Experts have also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it is not in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The IASc said trials for a vaccine involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial), and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.

Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials, it added.

The IASc said the immune responses usually take several weeks to develop and relevant data should not be collected earlier.

"Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted," it said.

For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.

For these reasons, the Indian Academy of Sciences believes that the announced timeline is "unreasonable and without precedent", the statement said.

"The Academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India," it said.

New Delhi, Mar 4: The government on Wednesday permitted NRIs to own up to 100 per cent stake in disinvestment-bound Air India.

The decision comes at a time when the government is looking to sell 100 per cent stake sale in the national carrier.

Union minister Prakash Javadekar said the Cabinet has approved allowing Non-Residents Indians (NRIs) to hold up to 100 per cent stake in Air India.

Allowing 100 per cent investment by Non-Resident Indians (NRIs) in the carrier would also not be in violation of SOEC norms. NRI investments would be treated as domestic investments.

Under the Substantial Ownership and Effective Control (SOEC) framework, which is followed in the airline industry globally, a carrier that flies overseas from a particular country should be substantially owned by that country's government or its nationals.

Currently, NRIs can acquire only 49 per cent in Air India. Foreign Direct Investment (FDI) in the airline is also 49 per cent through the government approval route.

As per the existing norms, 100 per cent FDI is permitted in scheduled domestic carriers, subject to certain conditions, including that it would not be applicable for overseas airlines.

In the case of scheduled airlines, 49 per cent FDI is permitted through automatic approval route and any such investment beyond that level requires government nod.

On January 27, the government came out witha Preliminary Information Memorandum (PIM) for Air India disinvestment. It has proposed selling 100 per cent stake in Air India along with budget airline Air India Express and the national carrier's 50 per cent stake in AISATS, an equal joint venture with Singapore Airlines.

Under the latest disinvestment plan, the successful bidder would have to take over only debt worth Rs 23,286.5 crore while the liabilities would be decided depending on current assets at the time of closing of the transaction.

This is the second attempt by the government in as many years to divest Air India, which has been in the red for long.

New Delhi, Jun 25: After the Drug Controller General of India (DCGI) given its approval to manufacture and market the generic version of COVID-19 drug Remdesivir, COVIFOR, Hyderabad-based drugmaker Hetero Limited has delivered the first set of 20,000 vials in two equal lots of 10,000 each across 5 states.

The first batch, which is being marketed under the brand name of COVIFOR, was delivered to Maharashtra, Delhi, Gujarat Tamil Nadu and Hyderabad. Hetero has set a target to produce one lakh vials of the drug in two-three weeks.

The other lot would be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Trivandrum and Goa within a week to meet the emergency requirements.

Managing director of Hetero Healthcare M Srinivasa Reddy said “the launch of Covifor in the country is a milestone in addressing public health emergencies. Through Covifor, we hope to reduce the treatment time of a patient in a hospital thereby reducing the increasing pressure on the medical infrastructure overburdened ue to accelerating COVID-19 infection rates," he said as reported by news agency.

"We are closely working with the government and the medical community to make Covifor quickly accessible to both public and private healthcare settings across the country”, Reddy said.

Covifor is a generic brand of Remdesivir which is used for the treatment of COVID-19 in adults and children hospitalised with strong symptoms of the disease. The Health Ministry had, on June 13, recommended the use of anti-viral drug Remdesivir in moderate stage of COVID-19.

Dr Reddys Laboratories and Hetero are among others which have separately entered into non-exclusive licensing agreements with the original drug-maker Gilead Sciences Inc to register, make and sell the investigational drug Remdesivir in India and other countries.

Remdesivir would be made in the company's formulation facility in Hyderabad, which has been approved by global regulatory authorities such as US Food and Drug Administration (USFDA) and EU, among others, Hetero had earlier said.

The treatment first showed improvement in trials on coronavirus patients and was approved for emergency use in severely ill patients in the United States and South Korea.